A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
A Multicentre Phase III Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
The main objective of this study is to establish interferon-beta-1a as the treatment of choice for chronic Hepatitis C with better efficacy and safety profiles in monotherapy or combination therapy.
This will be a multicenter, randomized, double-blind, placebo-controlled study with a placebo to be crossed-over to a combination of interferon-beta-1a and ribavirin or no treatment during an open-label extension phase. The duration of the trial will be 48 weeks, with a double-blind period of 12 weeks.
The study will recruit 257 eligible subjects of either sex. It will be conducted by approximately 16 Investigators / investigational centers in 3 countries (China, Hong Kong and Singapore).
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 3
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age between 18 and 65 years
- Have an elevated serum alanine aminotransferase (ALT) between 1.5 and 10 times the upper limit of normal
- Had adequate bone marrow reserve and organ function
- Are not pregnant and are willing to use contraception, if, of childbearing potential
- Are willing and able to comply with the protocol and to give written informed consent
- Other protocol defined inclusion criteria may apply
Exclusion Criteria:
- Clinical evidence of liver cirrhosis or a diagnosis of definite cirrhosis on liver biopsy
- History of liver failure, severe retinopathy, immunologically mediated disease, cancer or epilepsy with a history of inadequately controlled seizures
- Any cause for the liver disease other than chronic hepatitis C
- Evidence of chronic renal impairment, liver cancer, unstable psychiatric disorder, known or ongoing alcohol or drug abuse
- Positive test at screening for Hepatitis B surface antigen, immunoglobulin M Hepatitis B core antibody and human immunodeficiency virus antibody
- Previous systemic treatment for Hepatitis C with an interferon or ribavirin
- Presence of systemic disease that might interfere with subject safety, compliance or evaluation
- Known allergies to acetaminophen, human serum albumin or mannitol;
- Glucocorticosteroids or other immunosuppressive drugs taken within 28 days of starting treatment
- Bearing organ transplants (except cornea)
- Other protocol defined exclusion criteria may apply
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Interferon-beta-1a
|
Interferon-beta-1a will be administered subcutaneously at a dose of 44 microgram (mcg), three times a week up to Week 24
|
アクティブコンパレータ:Ribavarin plus interferon-beta-1a
|
Matching placebo will be administered subcutaneously three times a week for 12 weeks.
The placebo responders will continue the study off-treatment after Week 12 up to Week 24
Placebo non-responders at Week 12 will receive ribavirin at a dose of 1000 milligram (mg) or 1200 mg orally once daily in combination with Interferon-beta-1a, administered subcutaneously at a dose of 44 mcg three times a week, from Week 16 up to Week 24
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Percentage of subjects achieving sustained viral response (SVR) at Week 24
時間枠:Week 24
|
Week 24
|
Percentage of subjects achieving sustained viral response (SVR) at Week 48
時間枠:Week 48
|
Week 48
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Change from baseline in viral load (Hepatitis C virus ribonucleic acid [HCV RNA]) at Week 12, 24, and 48
時間枠:Baseline, Week 12, 24, and 48
|
Baseline, Week 12, 24, and 48
|
Percentage of subjects with Alanine transaminase (ALT) normalization
時間枠:Week 12, 24, and 48
|
Week 12, 24, and 48
|
Percentage of subjects with viral clearance
時間枠:Week 12 and 24
|
Week 12 and 24
|
Percentage of subjects with both SVR and sustained ALT normalization
時間枠:Week 48
|
Week 48
|
Number of subjects with improvement in the liver necroinflammation score by at least two points
時間枠:Week 48
|
Week 48
|
Number of subjects with improvement in architectural staging (liver fibrosis) by at least one point
時間枠:Week 48
|
Week 48
|
Number of subjects with adverse events and serious adverse events
時間枠:Baseline up to Week 48
|
Baseline up to Week 48
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Theodor Wee, M.D.、Serono Singapore Ltd, an affiliate of Merck Serono SA, Singapore
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 23744
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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